DMEK/DSAEK Infusion Sleeve

Basic Information

• Brand Name: DMEK/DSAEK Infusion Sleeve
• Primary DI: 00632307002205
• Version / Model: PD500.27
• Company Name: PEREGRINE SURGICAL, LTD.
• Labeler DUNS: 622467348
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-02-01
• Public Version: 7
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: bd9d3616-3cd7-4840-8173-5676df0551c3
• Distribution End Date: 2018-05-15

Device Description

DMEK/DSAEK Infusion Sleeve

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYG	Device, Irrigation, Ocular Surgery	Ophthalmic	886.4360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46705	Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use	A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10632307002202	GS1		5	Not in Commercial Distribution	2018-05-15
Primary	00632307002205	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]